Dry eye is a common ophthalmic disease caused by eye maladjustment due to meibomian gland dysfunction (MGD), which is often accompanied by symptoms such as increased tear film osmotic pressure and ocular surface inflammation. In the treatment of dry eye patients, dredging gland obstruction caused by meibomian gland secretion is an effective treatment method. Based on electrothermal effect and hyperelasticity of the silicone, an auxiliary treatment instrument for MGD is designed, which can improve the blood circulation of the glands through heat compress and massage to achieve the purpose of dredging the meibomian glands. The therapy device can display the temperature and pressure during the treatment in real time, so that the surgeon can grasp the progress of the treatment in real time. The therapy device constructs a user-oriented interactive interface based on parametric modeling method, which can be customized by 3D printing according to the user's eyeball geometric parameters. The designed therapeutic device was finally tested on New Zealand white rabbits. The experimental results show that the therapeutic device has significant effectiveness and safety, as well as clinical application prospects.
Animals ; Dry Eye Syndromes/therapy* ; Humans ; Meibomian Gland Dysfunction ; Meibomian Glands ; Rabbits ; Tears ; Treatment Outcome

OBJECTIVE: To evaluate the safety and effectiveness of eyelid margin cleaning using Deep Cleaning Device for the treatment of meibomian gland dysfunction-associated dry eye. METHODS: This was a prospective, randomized, open-label, investigator-masked, and self-controlled study. We randomly assigned one eye of patients with meibomian gland dysfunction-associated dry eye to the treatment group, and the other eye to the control group. Both groups received artificial tears and lid warming; the treatment group received an additional one-time in-office eyelid margin cleaning using Deep Cleaning Device. Non-invasive tear break-up time (NITBUT) and tear meniscus height (TMH) of each eye, and Standard Patient Evaluation for Eye Dryness II (SPEED II) score of each patient were evaluated before and at one week after treatment. RESULTS: Thirty eyes of 15 patients were enrolled. No adverse effects occurred during the treatment. Compared with the baseline values, the SPEED score decreased significantly at one week after treatment (mean±95% confidence interval, 11.00±0.99 vs. 5.67±1.67, P<0.0001), the NITBUT-first in the treatment group increased significantly at one week after treatment ((4.74±1.27) s vs. (7.49±2.22) s, P=0.01). The NITBUT-first was significantly longer in the treatment group ((7.49±2.22) s) than in the control group ((5.17±0.91) s) at one week after treatment (P=0.042). No significant differences were found in other tear film parameters between the two groups. CONCLUSIONS Eyelid margin cleaning using the novel Deep Cleaning Device is a convenient, effective, and safe treatment for patients with meibomian gland dysfunction-associated dry eye.
Adult ; Aged ; Dry Eye Syndromes/therapy* ; Eyelids/physiopathology* ; Female ; Humans ; Hyperthermia, Induced ; Male ; Meibomian Gland Dysfunction/therapy* ; Middle Aged ; Prospective Studies ; Tears